CMCiB renews its certificate of compliance with Good Laboratory Practices (GLP) for the preclinical validation of medical devices

The Comparative Medicine and Bioimaging Centre of Catalonia (CMCiB) of the Germans Trias i Pujol Research Institute (IGTP) has renewed its certificate of compliance with Good Laboratory Practices (GLP) in accordance with Directive 2004/9/EC.

The centre meets the criteria defined by Royal Decree 822/19932 for the conduct of preclinical studies in areas necessary for the validation of medical devices' efficacy, biocompatibility, and tolerance. To achieve this accreditation, CMCiB has a team of professional experts who serve as study directors and GLP quality technicians and has received support from the external Quality Assurance Unit of FalcoQuality.

Good Laboratory Practices are the highest quality standard that CMCiB offers to its clients in the pharmaceutical and medtech (medical devices) sectors, ensuring that data obtained during product validation trials are reliable, reproducible, and auditable, following international criteria recognised by regulatory agencies. The reaccreditation of the centre and obtaining the GLP compliance certificate underscore the trajectory and quality of CMCiB's services for medical device validation and the goal of achieving excellence in research and translating results into clinical practice.

With this regulatory milestone, the CMCiB consolidates itself as one of the few national public research centres with GLP certification specialised in the validation of medical devices (registration code GLP059CAT) and strictly adheres to international research standards for preclinical studies. The animal care and welfare program, professional training, documentation of the studies conducted, and the facilities and equipment of the advanced surgery area, as well as the animal housing facilities, have been inspected for the renewal of its certification. These spaces and equipment include highly equipped operating rooms, and imaging technologies such as ultrasound, magnetic resonance imaging, and interventional vascular radiology.

The official certification document, granted by the Generalitat de Catalunya, assures the excellence and reliability of the results obtained in the validation studies conducted at the centre. It also represents CMCiB's commitment to international quality criteria in translational research. Since 2021, it has been required by law that medical products, such as prostheses, catheters, valves, stents, and surgical devices, be preclinically validated according to this GLP accreditation. A study guide, meticulous documentation of the work performed, and a final report of results are necessary for regulatory agencies to authorize the use of the new product in clinical trials and for its subsequent commercialization.

The achievement of this certification contributes to consolidating the CMCiB-IGTP as a tool for transferring research and innovation to society and improving the healthcare system and people's health through new medical solutions reaching the market.

Participation in the GLP Validation Studies of Embolizing Products from iVascular and the Rob Surgical Robot

Since the centre's inception, the advanced surgery team has been involved in development and functional validation projects for a wide range of medical devices in various therapeutic areas and for different indications, such as prostheses, catheters, valves, stents, embolizing fluids, biodegradable implants, etc., which have been fundamental in achieving the experience and establishing the quality and demanding system required for GLP certification. During the previous accreditation period, the centre marked a significant advance by incorporating its first GLP studies for medtech clients.

The company iVascular, founded in 2010 in Barcelona with the aim of developing medical devices and therapies for the treatment of vascular system disorders, has been a key client in the development of the first GLP studies at CMCiB, contributing to building a portfolio of projects and a trajectory of multiple safety, efficacy, and technical viability studies in a porcine model with some of its embolizing products. In its pipeline, iVascular has a wide range of coronary, peripheral, and neurointerventional products with solid scientific evidence within its iVasTriam clinical trials program, demonstrating the efficacy and safety of the products.

In anticipation of the upcoming clinical transition of the products tested at CMCiB, training workshops have been conducted and promoted by the company to specialists in interventional radiology at the CMCiB facilities. From the GLP studies conducted at CMCiB and the products tested, specifically, one of them has already progressed to human clinical trials, following international Good Clinical Practice (GCP) standards. CMCiB has contributed to the preclinical trials of the Rob Surgical Bitrack, a robotic system that has successfully completed the second series of surgeries with patients at the Hospital Clínic and is still in the final phase of European certification, being the first surgical robot conceived and developed in Catalonia. These advances have positioned CMCiB as a benchmark in technological transfer and medical innovation.

Reference Centre in the Validation of Medical Devices

As a reference centre in the validation of medical devices, in addition to the GLP validation of iVascular and Rob Surgical products and new medical device candidates in the portfolio this year, CMCiB has positioned itself over the years as a reference centre in the territory for the validation of new and complex technologies.

Recently, an important early-phase multicentric clinical study (first-in-human, FIH) for patients with coronary microvascular dysfunction or microvascular angina has been initiated, using an innovative therapy developed by VahatiCor Inc, an international client of the centre specialised in developing medical devices addressing unmet medical needs for cardiac patients. CMCiB has carried out preclinical validation functional studies with the A-FLUX Reducer performed in their state-of-the-art surgical facilities, as well as specialised training for reference clinicians, enabling them to use the new product in people in the planned trials, reaffirming CMCiB's position as a reference centre in the validation of medical devices within various therapeutic areas.

The A-FLUX Reducer, implanted in the coronary sinus -the largest vein of the heart-, has been designed to improve blood flow in ischemic areas of the heart, with the aim of alleviating symptoms and enhancing the quality of life of patients.

This success story demonstrates the capability of new technologies to meet unmet medical needs, by "providing predictable and low-risk treatments for a growing population of patients with angina symptoms who do not achieve satisfactory results with conventional medications or lifestyle changes", as noted by VahatiCor.

Good Laboratory Practices (GLP)

Good Laboratory Practices (GLP) constitute a quality framework that regulates how research laboratories organize and conduct non-clinical studies focused on the health and environmental safety of various substances and chemicals. This quality framework establishes standards for planning, conducting, monitoring, documenting, and storing these studies, essential for the homologation and/or approval of chemicals intended for human and veterinary use, including medicines, cosmetics, healthcare products, pesticides, phytosanitary products, food additives for human and animal consumption, and industrial chemicals.

Since 1995, in Catalonia, the responsibility for ensuring adherence to GLP principles for studies related to the health and environmental safety of drugs and healthcare products, according to the guidelines of the Organisation for Economic Co-operation and Development (OECD) and the European Union, lies with the Department of Health of the Generalitat de Catalunya, more specifically the Pharmaceutical Control and Healthcare Products Service of the Directorate General for Healthcare Regulation.

CMCiB adheres to the criteria defined by Royal Decree 822/19932 in conducting preclinical studies on healthcare products, incorporating analytical evaluations and clinical chemistry (hematology and biochemistry) in the dosing studies of test products and sample collection, as well as the biocompatibility study of healthcare products.